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Clinical Data Management
APIS Professional Program

Clinical Data Management

Comprehensive clinical data collection, validation, query management, data cleaning, reconciliation, CDISC standards and database management.

Course Overview

Clinical Data Management (CDM) is the process of collecting, validating, cleaning, managing, and maintaining clinical trial data to ensure its accuracy, completeness, consistency, and reliability.

Course Modules

Module 1: Introduction to Clinical Data Management

  • Definition and Scope of CDM
  • Role of CDM in Clinical Trials
  • Drug Development Process Overview
  • Clinical Research Basics
  • CDM Workflow Overview
  • Importance of Data Quality
  • CDM Career Opportunities

Module 2: Clinical Trial Fundamentals

  • Clinical Trial Phases
  • Study Design Basics
  • Clinical Trial Terminology
  • Protocol Overview
  • Study Objectives and Endpoints
  • Investigator Responsibilities
  • Sponsor Responsibilities

Module 3: ICH-GCP and Regulatory Guidelines

  • Introduction to ICH
  • ICH-GCP Guidelines
  • ALCOA+ Principles
  • FDA Regulations
  • EMA Regulations
  • CDSCO Guidelines
  • Data Integrity Requirements
  • Regulatory Compliance in CDM

Module 4: Clinical Trial Documents

  • Study Protocol
  • CRF
  • eCRF
  • Data Management Plan
  • Data Validation Plan
  • Trial Master File
  • Study Documentation Standards

Module 5: CRF/eCRF Design

  • CRF Development Process
  • eCRF Design Principles
  • Data Collection Standards
  • Form Layout Design
  • Field Specifications
  • Edit Check Planning
  • Annotation Process

Module 6: Database Design & Setup

  • Database Development Lifecycle
  • Clinical Database Structure
  • Database Setup Process
  • User Access Management
  • Role-Based Permissions
  • Database Testing
  • User Acceptance Testing

Module 7: Clinical Data Collection

  • Source Data Collection
  • Electronic Data Capture
  • Data Entry Procedures
  • Remote Data Entry
  • Data Verification
  • Data Transfer Methods
  • Data Handling Procedures

Module 8: Data Validation

  • Data Validation Concepts
  • Edit Checks
  • Range Checks
  • Consistency Checks
  • Logical Checks
  • Missing Data Checks
  • Validation Specifications

Module 9: Query Management

  • Query Generation
  • Manual Queries
  • Automatic Queries
  • Query Resolution Process
  • Investigator Communication
  • Query Tracking
  • Query Closure Process

Module 10: Data Cleaning

  • Data Review Process
  • Data Reconciliation
  • Medical Coding Reconciliation
  • SAE Reconciliation
  • Laboratory Data Review
  • External Data Reconciliation
  • Data Quality Review

Module 11: Medical Coding in CDM

  • Introduction to MedDRA
  • MedDRA Hierarchy
  • Adverse Event Coding
  • Coding Review Process
  • WHO Drug Dictionary
  • Drug Coding Concepts
  • Concomitant Medication Coding
  • Drug Dictionary Management

Module 12: Clinical Database Systems

  • Oracle Clinical
  • Medidata Rave
  • Veeva Systems
  • REDCap
  • OpenClinica
  • EDC System Basics

Module 13: Data Reconciliation

  • SAE Reconciliation
  • Pharmacovigilance Reconciliation
  • Laboratory Data Reconciliation
  • External Vendor Data Reconciliation
  • Discrepancy Management
  • Data Consistency Verification

Module 14: Database Lock & Study Closure

  • Pre-Lock Activities
  • Database Lock Process
  • Data Freeze Concepts
  • Final Data Review
  • Archiving Procedures
  • Study Close-Out Activities

Module 15: Data Quality Management

  • Quality Control
  • Quality Assurance
  • Data Review Metrics
  • Risk-Based Data Review
  • Audit Readiness
  • CAPA Management

Module 16: CDISC Standards

  • Introduction to CDISC
  • SDTM Basics
  • ADaM Basics
  • CDASH Overview
  • Clinical Data Standards
  • Regulatory Submission Standards

Module 17: Clinical Data Management Technologies

  • Electronic Data Capture
  • Interactive Response Technology
  • ePRO Systems
  • eCOA Systems
  • CTMS Overview
  • Clinical Data Platforms

Module 18: Clinical Data Management Career Development

  • Clinical Data Coordinator
  • Clinical Data Associate
  • Clinical Data Analyst
  • Data Manager
  • Lead Data Manager
  • Project Data Manager
  • Career Progression Path

Practical Training

✅ CRF/eCRF Design Demonstration
✅ Database Setup Demonstration
✅ Edit Check Creation
✅ Query Management Exercises
✅ Data Cleaning Activities
✅ SAE Reconciliation Exercises
✅ MedDRA Coding Practice
✅ WHO Drug Coding Practice
✅ Database Lock Simulation
✅ Real-Time Clinical Data Review Scenarios

Interview Preparation

🎯 CDM Interview Questions
🎯 HR Interview Preparation
🎯 Resume Building Guidance
🎯 LinkedIn Profile Optimization
🎯 Professional Communication Skills
🎯 Email Writing Basics
🎯 Corporate Etiquette

What You'll Achieve

Gain comprehensive knowledge of clinical data collection, validation, query management, data cleaning, reconciliation, CDISC standards, database management and regulatory compliance.